Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3202—Devices for protection of the needle before use, e.g. caps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3202—Devices for protection of the needle before use, e.g. caps
  • A61M5/3204—Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
  • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/3257—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
  • A61M2005/3258—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means being compressible or compressed along the needle
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
  • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/19—Constructional features of carpules, syringes or blisters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
  • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
  • A61M2205/586—Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
  • A61M5/3272—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position having projections following labyrinth paths
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

Definitions

• the embodiments provided herein relate generally to safety systems for Syringes, and more particularly to a needle guard for a syringe that includes an automatically activated shield for covering a needle of the syringe.
• Medication is often dispensed using a medicine cartridge, such as a glass syringe, having a barrel with a needle at one end and a plunger slidably inserted into the other end and coupled to a rubber stopper.
• a medicine cartridge such as a glass syringe, having a barrel with a needle at one end and a plunger slidably inserted into the other end and coupled to a rubber stopper.
• Such cartridges are often referred to as "pre-filled syringes" because they may contain a specific dosage or volume of medication when they are initially provided, as compared to conventional syringes that are furnished empty and filled by the user before making an injection.
• the glass syringe and rubber stopper have, for years, provided an ideal drug storage closure having unique properties of impermeability to oxygen, low extractables, biocompability, durability, etc. However, they are both formed by processes that do not lend themselves to tight geometrical tolerances. Tight tolerances were not originally needed by these
• Prefilled syringes tend to be shipped to pharmaceutical customers as ready-to-fill syringes, which are syringes that have been thoroughly cleaned inside and outside after the forming processes and attachment of a needle have been completed, and then placed in sealed tubs that are then sterilized and shipped to the pharmaceutical customers ready for filling with a medicine.
• the syringe tubs may contain 100 to 160 syringes, each with a geometrical spacing and access that is consistent with established syringe handling equipment.
• a safety device applied to the syringe must not obscure the optical inspection systems that are in place to check the syringes prior to filling them with medication.
• a needle guard for a ready-to-fill syringe having the safety device triggering mechanism independent of the syringe and stopper tolerances, and that assembles to the syringe without adversely affecting the syringe position with respect to the syringe handling tub or the way the handling equipment conveys the syringes during filling and packaging nor impedes the inspection processes.
• a contact trigger release needle guard device described herein is an anti-needle stick device designed to be attached to the distal end of a ready-to-fill syringe.
• the needle guard device includes a lock collar and a device shield moveable relative to the lock collar.
• the device shield is biased relative to the lock collar by an elastic spring coupled between the device shield and the lock collar.
• the lock collar interfaces with a syringe neck and recess to attach the needle guard device to the ready-to-fill syringe.
• the device shield With the removal of a rigid needle shield subassembly comprising rigid and soft needle shield components, the device shield is free to move proximally along the syringe neck and interact with the lock collar triggering the device shield to move relative to the lock collar from a first configuration, where the device shield is moveable to expose a syringe sharp to a second configuration where the needle is fixedly shielded or covered.
• a device user removes the rigid needle shield subassembly, inserts the syringe sharp, such as a needle, into an injection site and pushes down on the syringe past the point of initial contact of the device shield with the skin, moving the device shield proximally along the lock collar.
• Figure 1 is an isometric view of an exploded assembly of a safety device with a syringe.
• Figure 2 is an isometric view of a lock collar and a device shield after a first step (polymer injection molding - 1 st shot) in a process of manufacturing the integrated lock collar, device shield, and flexible interconnect part.
• Figure 3 is an isometric view of the lock collar, device shield, and flexible interconnect after a second step (TPE injection molding - 2nd shot) in the process of manufacturing the integrated lock collar, device shield, and flexible interconnect part.
• Figure 4 is an isometric view of the lock collar, device shield, and flexible interconnect after a third step (clipping of the lock collar/device shield bridges) in the process of manufacturing the integrated lock collar, device shield, and flexible interconnect part.
• Figure 5 is an isometric view of the integrated lock collar, device shield, and flexible interconnect part assembled together with the lock collar inserted into the device shield.
• Figure 6 is a cross sectional view of the integrated lock collar, device shield, and flexible interconnect part assembled together with the lock collar inserted into the device shield.
• Figure 7 is a cross sectional view of the safety device assembled to a syringe neck with a rigid needle shield (RNS) in place prior to use.
• RNS rigid needle shield
• Figure 8 is a front view of a syringe with a custom neck for integration with the safety device.
• Figure 9 is a top view of the lock collar of the safety device.
• Figure 10 is an isometric view of the RNS with an integrated grip for easy removal from the safety device.
• Figure 1 1 is an isometric cross sectional view of the RNS.
• Figure 12 is an isometric view of the safety device fully assembled with a syringe and a plunger, and with the RNS removed. The device is depicted as pressed against the skin of a patient ready to insert the needle into the injection site.
• Figure 13 is a cross sectional, partial isometric view of the safety device fully assembled with a syringe, and with the RNS removed. The safety device is depicted as pressed against the skin of a patient ready to insert the needle into the injection site.
• Figure 14 is a cross sectional, isometric view of the device prior to inserting the needle into the injection site showing a ramp within the lock collar which device shield lock arms travel up.
• Figure 15 is an isometric view of the lock collar.
• Figure 16 is an isometric view of the safety device prior to needle insertion into the injection site with a portion of the device shield and flexible interconnect cut away. This view shows a lock collar rotation arm and its alignment with an angled cutout within the device shield.
• Figure 17 is a cross sectional view through the top of the safety device revealing the rotational dependence of the device shield and lock collar via a key on the device shield and a keyway within the lock collar.
• Figure 18 is a cross sectional isometric view of the device shield.
• Figure 19 is an isometric detail view of the lock collar rotation arm as it has engaged with the device shield angled cutout during needle insertion.
• Figure 20 is an isometric view of the safety device during needle insertion as the lock collar rotation arm has engaged with the device shield angled cutout during needle insertion.
• Figure 21 is an isometric, cross sectional view through the safety device during needle insertion which shows the direction of rotation of the device shield relative to the lock collar and the device shield key's ability to flex from the keyway at the point of needle insertion.
• Figure 22 is a, cross sectional view viewed from the proximal end through the safety device during needle insertion which shows the direction of rotation of the device shield relative to the lock collar and the device shield key's ability to flex from the keyway at the point of needle insertion.
• Figure 23 is an isometric view of the safety device at full needle insertion with the lock collar rotation arm at point B of the device shield angled cutout.
• Figure 24 is a detail view of the lock collar rotation arm at point B of the device shield angled cutout at full needle insertion.
• Figure 25 is an isometric, cross sectional view of the safety device after full needle insertion, showing the device shield key locked rotationally with the lock collar tab.
• Figure 26 is a cross sectional (90 degrees offset from Figure 18) isometric view of the device shield.
• Figure 27 is an isometric, cross sectional view of the safety device after full needle insertion, showing the device shield cutout, in place to relieve any stress on the lock collar rotation arm.
• Figure 28 is an isometric view of the safety device upon needle removal as a device shield lockout arm re-engages with the lock collar.
• Figure 29 is a detail, cross sectional view of the safety device upon needle removal as the device shield lockout arm re-engages with the lock collar.
• Figure 30 is a cross sectional, partial isometric view of the device after needle removal and device lockout.
• Figure 31 is a detail, cross sectional, isometric view of the device after needle removal and device lockout with the device shield lockout arm in lockout position.
• Figure 32 is a partial isometric view of an alternate lockout method embodiment with a portion of the device shield cut away to view the inside of the device.
• the alternate lockout method embodiment is shown in a state prior to device use.
• Figure 33 is a partial isometric view of an alternate lockout method embodiment prior to device use.
• Figure 34 is a partial isometric view of an alternate lockout method embodiment after the needle has been inserted partway into the injection site.
• Figure 35 is a cross sectional partial isometric view of the alternate lockout method embodiment after the needle has been inserted partway into the injection site.
• Figure 36 is an isometric view of a lock ring used in the alternate lockout method embodiment.
• Figures 37 A and B are cross sectional partial isometric views of an alternate lockout method embodiment after the needle has been inserted fully into the injection site.
• Figures 38 A and B are cross sectional partial isometric views of the alternate lockout method embodiment after the needle has been fully removed from the injection site and the device is in the locked state.
• FIG. 1 - 38 show embodiments of a contact trigger release needle guard.
• the needle guard described herein is an anti-needle stick safety device designed to be attached to the distal end of a prefilled syringe in its ready- to-fill state.
• an anti-needle stick safety device or needle guard 100 is designed to be attached to the distal end of a syringe 50 in its ready-to-fill state.
• the device 100 is comprised of a lock collar 10, a device shield 20, a flexible
• the lock collar 10, device shield 20, and flexible interconnect 30 are produced in one injection molding process.
• the process consists of injection molding the lock collar 10 and device shield 20 in a first injection molding shot with a single polymer material. As depicted in Figure 2, the two parts may be connected via a thin bridge 60 of material or via a runner system in what is typically known as a family mold.
• a second injection molding shot would consist of a flexible material such as a thermoplastic elastomer (TPE), which would produce a flexible interconnect 30 that physically connects the lock collar 10 to the device shield 20 as shown in Figure 3.
• TPE thermoplastic elastomer
• the flexible interconnect 30 would physically bond to the lock collar 10 and device shield 20.
• the lock collar 10 and device shield 20 may be designed such that when the flexible interconnect 30 is injection molded, a physical mechanical bond is created between the parts. The last step in the process is to clip off the bridge
• the safety device 100 is depicted in Figure 4 without the bridge 60.
• the lock collar 10 is pushed or inserted within the device shield 20. This step is made possible by the flexibility of the flexible interconnect 30, which is coupled to and positioned between the lock collar 10 and device shield 20.
• the device 100 is shown assembled to the syringe 50 via a recess 52 in the syringe neck 53 and lock collar tabs 1 1 located on the inner diameter of the lock collar 10.
• the rigid needle shield 40 is attached to the distal end of the syringe 54.
• the rigid needle shield 40 is comprised of an outer rigid thermoplastic 41 , and inner soft elastomeric needle shield 42, as is currently marketed and often used on glass, pre-filled syringes to protect the needle and drug such as, e.g., the Stelmi rigid needle shield or the BD rigid needle shield.
• the distal end of the syringe 54 is designed to be identical to a standard 1 ml long pre-filled glass syringe. Consequently, the rigid needle shield 40 functions identically to current pre-filled syringe rigid needle shield systems, protecting both the needle sharp 51 and the contents of the syringe 50 by creating a seal between the soft needle shield component 42 and the bulbus 55 of the syringe, and the soft needle shield component 42 and the syringe sharp 51 .
• the rigid needle shield 40 also contains a grip section 43 extending from the outer rigid portion 41 , which protrudes from the bottom of the device shield 20 as depicted in Figure 7.
• the grip 43 is available to the user to grab and remove the rigid needle shield 40 prior to use of the syringe 50 and safety device 100. After removal of the rigid needle shield 40, the syringe 50 and safety device 100 is ready for drug injection.
• the flexible interconnect 30 is bonded or fixed to the distal end of the lock collar 10 and to the proximal end of device shield 20, and, as a result, as the syringe 50 is pushed distally, the lock collar 10, which is coupled to the syringe 50, travels distally relative to the device shield 20 causing the flexible interconnect 30 to be stretched, thereby storing energy, and thus, acting like a spring.
• a device shield lockout arm 22 rides up or proximally along a ramp 12 located on the lock collar 10 as shown in Figure 14. Consequently, the device shield lockout arm 22 flexes and will ride up or proximally along the syringe 50 in flexion during insertion of the needle 51 into the injection site 70.
• an angled cutout 23 is shown in the device shield 20 and a rotation arm 14 is shown on the lock collar 10. The rotation arm 14 is aligned vertically with the beginning point (Point
• the device shield 20 and lock collar 10 will begin to rotate relative to one another.
• an angled or chamfered surface 27 on the device shield key 25 and a cutout 28 within the device shield 20 allows the device shield key 25 to flex out from the keyway 15 and travel over a lock collar tab 17.
• the device shield 20 and lock collar 10 prefferably be fixed rotationally at this point of device use, otherwise the torsion created in the flexible interconnect 30, as a result of twisting the device shield 20 in relation to the lock collar 10 during needle 51 insertion, would tend to force the device shield 20 and lock collar 10 to resile to their original orientations relative to one another upon needle 51 removal. Such an occurrence, would tend to prevent the device shield 20 from properly locking in a shielded position upon full needle removal 51 from the injection site 70.
• the interface between the top or proximal edge 66 of the device shield lockout arm 22 and the top or distal surface 68 of the lock collar recess 19 causes the device shield 22 to be in locked state, permanently protecting and shielding the needle 51 .
• the interface between the bottom of lockout arm 22 and the bottom surface of the lock collar recess 19 prevents further distal movement of the device shield 20 relative to the syringe 50.
• FIG. 32 and 33 an alternate embodiment is shown to include a different device lockout method.
• a lock ring 150 is assembled to the lock collar 1 10 at its distal end before device use.
• the lock ring 150 contains two tabs 151 on each side which sit within two channels 121 within the device shield 120.
• the needle shield 120 moves proximally away from the injection site up the syringe 160 barrel such that the lock ring tabs 151 slide within the device shield channels 121 until the bottom surface 128 of the channels contact the lock ring tabs 151 .
• the lock ring 150 As the device shield 120 continues to move up the syringe 160 barrel and the needle further penetrates the injection site, the lock ring 150, as depicted in Figure 35, is carried with the device shield 120 up the shaft 1 12 of the lock collar 1 10 where it encounters a sloped ramp 1 14 on each side of the lock collar 1 10 and flexes over the sloped ramp 1 14. As shown in Figure 36, the lock ring 150 is shaped like the letter C which makes it flexible.
• the device shield 120 will move distally back down the syringe 160 barrel as was described in the previous embodiment due to the elasticity and spring force generated by the flexible interconnect 130.
• the device shield lockout arms 122 in a flexed beam state as the needle is being removed from the injection site, will transfer contact from the syringe 160 barrel to the lock ring protrusions 156, and, as shown in
• Figures 38A and 38B then snap into place under the protrusions 156. Since, as shown in Figure 32, the lock ring 150 is constrained vertically by the flat surface 1 15 of the lock collar sloped ramps 1 14 and the bottom surface of the lock collar lip 1 19, the shield 120 will be unable to move up or down relative to the syringe barrel 160, consequently locking the device and protecting the user from an accidental needle stick.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Environmental & Geological Engineering (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

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Applications Claiming Priority (4)

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• 2013
  • 2013-03-13 US US13/802,130 patent/US9278179B2/en active Active
  • 2013-06-19 CN CN201380038706.0A patent/CN104703645B/zh active Active
  • 2013-06-19 MX MX2014015791A patent/MX350938B/es active IP Right Grant
  • 2013-06-19 EP EP15190699.7A patent/EP3006070B1/en active Active
  • 2013-06-19 ES ES17203217T patent/ES2718452T3/es active Active
  • 2013-06-19 WO PCT/US2013/046618 patent/WO2013192328A1/en active Application Filing
  • 2013-06-19 ES ES13735119T patent/ES2595233T5/es active Active
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